RESPOND: RESynchronisation in Patients With Heart Failure and a Normal QRS Duration

Sponsor

Heart of England NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT00480051

Collaborator

Sandwell & West Birmingham Hospitals NHS Trust (Other)

Enrollment

Locations

31.1

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients who have heart failure and have electrical evidence of delay in the contraction of the left ventricle on an ECG tracing of the heart are eligible for biventricular pacing. Recent work has suggested that patients with heart failure who do not have electrical evidence of conduction delay (normal QRS) may benefit from biventricular pacing. The reliance on ECGs to determine the presence of dyssynchrony is widespread, although the ECG alone is not 100% sensitive and specific. ECG criteria for de-synchrony in heart failure patients are estimated to pick up only 30% of patients with dyssynchrony, and results in patients missing out on a potentially important treatment advance.

We would like to study patients with heart failure who have normal ventricular activation on their ECGs to see whether we can predict those patients who will respond to biventricular pacing.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Congestive	Device: Cardiac Resynchronization Pacing	Phase 3

Detailed Description

AIMS and Objectives A randomised controlled clinical trial

Primary objective

• Improvements in 6-min walking distance

Secondary objectives Determine

Symptomatic improvement in quality of life, using the Minnesota Living with Heart Failure questionnaire
Change in NT pro-BNP and echocardiographic parameters of LV function
Does MRI Dyssynchrony Index (CMR-TSI) predicts responders.
Morbidity and Mortality using CARE-HF definitions
Packer combined clinical composite score

Study Design A pilot randomised controlled clinical trial 60 patients. The biventricular pacemaker with be optimized for both A-V delay and V-V delay.

Subject Selection Source - Patients attending Good Hope Hospital, Sandwell Hospital Centres involved - 2 Eligible Participants - 60 patients with heart failure and narrow QRS.

Inclusion Criteria Sinus rhythm Symptomatic heart failure - NYHA class III or IV ECG QRS duration less than 120 milliseconds LV ejection fraction of less than 35% on echocardiography using Simpsons technique.

Able to give informed consent

Exclusion Criteria Age below 18 Current or planned pregnancy Patient refusal Ventricular tachycardia or ventricular fibrillation Current or recent (within last 30 days) involvement in other studies Requires implantable cardioverter defibrillator (ICD) according to NICE criteria for implantation (England and Wales)

Definition of clinical response:- 20% improvement in 6 minute walk distance or any improvement from 0

Definition of echocardiographic response:- 15% or greater decrease in left ventricular end systolic volume

Follow up 6 weeks and 6 monthly thereafter. Interim results at 6 months. Analysis of results, echocardiograms, MRI and BNP will be blind Walk distance to be measured by unblinded observer and by pedometer.

Randomisation:

Numbered envelopes will be prepared by sponsor (Heart of England NHS Foundation Trust) and kept from researchers. After informed consent, the patient will be enrolled and the technician will draw the result.

This trial was known as the Birmingham biventricular pacing in patients unselected for dyssynchrony (BIPIDS).

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

RESynchronisation in Patients With Heart Failure and a Normal QRS Duration

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Feb 1, 2010

Outcome Measures

Primary Outcome Measures

Improvements in 6-min walking distance [6 months]

Secondary Outcome Measures

Symptomatic improvement in quality of life, using the Minnesota Living with Heart Failure questionnaire [6 months]
Change in NT pro-BNP and echocardiographic parameters of LV function [6 months]
Does MRI Dyssynchrony Index (CMR-TSI) predicts responders [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Sinus rhythm
Symptomatic heart failure - NYHA class III or IV
ECG QRS duration less than 120 milliseconds
LV ejection fraction of less than 35% on echo
Able to give informed consent

Exclusion Criteria:

Age below 18
Current or planned pregnancy
Patient refusal
Ventricular tachycardia or ventricular fibrillation
Current or recent (within last 30 days) involvement in other studies
Requires implantable cardioverter defibrillator (ICD)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sandwell Hospital	Birmingham		United Kingdom	B71 4HJ
2	Good Hope Hospital	Sutton Coldfield		United Kingdom	B75 7RR

Sponsors and Collaborators

Heart of England NHS Trust
Sandwell & West Birmingham Hospitals NHS Trust

Investigators

Study Chair: Francisco Leyva, MD MB BS, University of Birmingham
Principal Investigator: Paul W Foley, MB ChB MRCP, Heart of England NHS Foundation Trust
Principal Investigator: Kiran Patel, PhD MRCP, Sandwell & West Birmingham Hospitals NHS Trust
Principal Investigator: Berthold Stegemann, PhD, Bakken Research Centre, The Netherlands
Principal Investigator: Russell EA Smith, FRCP MD, University Hospital Birmingham